Cesarean SectionNCT02692729
Transverse Supraumbilical Versus Pfannenstiel Incision for Cesarean Section in Morbidly Obese Women
A study testing transverse supraumbilical and pfannenstiel incision in people with Cesarean Section, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to evaluate the efficacy and safety of transverse supraumbilical incision over Pfannenstiel incision in performing cesarean section for morbid obese pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- transverse supraumbilical and pfannenstiel incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- BMI more than 40 kg/m2
- women scheduled for CS
Who cannot join
- patients receiving steroids or anticoagulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transverse Supraumbilical Versus Pfannenstiel Incision For Cesarean Section in Morbid Obese Patients" A Single Blinded Randomized Controlled Trial"
This study aims to evaluate the efficacy and safety of transverse supraumbilical incision over Pfannenstiel incision in performing cesarean section for morbid obese pregnant women.
Read the detailed description
Research Question In Morbidly obese women undergoing cesarean section, is transverse supraumbilical incision superior to Pfannenstiel incision? Research Hypothesis Transverse supraumbilical incision is superior to Pfannenstiel incision in morbidly obese women undergoing cesarean section.
- Conditions
- Cesarean Section
- Being tested
- transverse supraumbilical, pfannenstiel incision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transverse supraumbilicalProcedure or surgery
transverse Supraumbilical Incision, in which the skin incision is a straight transverse skin incision slightly higher than the Pfannenstiel (5- 6) cm. from the upper border of the symphysis pubis The high transverse incision facilitated access to the fascia of the rectus abdominalis
pfannenstiel incisionProcedure or surgery
Pfannenstiel Incision, in which the skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 ) cm.
| Study group | Role | What they receive |
|---|---|---|
| supraumbilical transverse | Experimental | transverse Supraumbilical Incision, in which the skin incision is a straight transverse skin incision slightly higher than the Pfannenstiel (5- 6) cm. from the upper border of the symphysis pubis The high transverse incision facilitated access to the fascia of the rectus abdominalis. Above the panniculus, the fatty tissues are not particularly thick. A transverse opening of the aponeurosis and of the parietal peritoneum was done. Then the approach to the lower uterine segment was easy. A Ricard retractor was put in place. Receives: Procedure: transverse supraumbilical |
| pfannenstiel | Active comparator | Pfannenstiel Incision, in which the skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 ) cm. Receives: Procedure: pfannenstiel incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurence of surgical site infection
occurance of redness, hotness, pus discharge and exudation
Measured: one week
Secondary outcomes (2)
operative time in minutes
from skin incision to closure of the skin
Measured: 2 hours
blood loss in milliliter
volume of blood during the operation
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University
- Investigators
- Ahmed M kotb, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692729
- Sponsor's protocol ID
- STIP
- Status last verified
- Jul 2016
- First submitted
- 23 Feb 2016
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
AbdElhady RM, Hamid ASA, El Sayed HM, El Mekkawi SF, Elhossary HMAF, El Kotb AM. Randomized trial assessing transverse supraumbilical incisions for cesarean sections in morbid obese women with pannus. BMC Pregnancy Childbirth. 2025 Dec 18;26(1):91. doi: 10.1186/s12884-025-08530-y.
PubMed 41413498
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transverse Supraumbilical Versus Pfannenstiel Incision For Cesarean Section in Morbid Obese Patients" A Single Blinded Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT02692729
- Acronym / sponsor ID
- STIP
- Conditions
- Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy and safety of transverse supraumbilical incision over Pfannenstiel incision in performing cesarean section for morbid obese pregnant women.
Detailed description
Research Question In Morbidly obese women undergoing cesarean section, is transverse supraumbilical incision superior to Pfannenstiel incision? Research Hypothesis Transverse supraumbilical incision is superior to Pfannenstiel incision in morbidly obese women undergoing cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supraumbilical transverse | Experimental | Procedure: transverse supraumbilicaltransverse Supraumbilical Incision, in which the skin incision is a straight transverse skin incision slightly higher than the Pfannenstiel (5- 6) cm. from the upper border of the symphysis pubis The high transverse incision facilitated access to the fascia of the rectus abdominalis. Above the panniculus, the fatty tissues are not particularly thick. A transverse opening of the aponeurosis and of the parietal peritoneum was done. Then the approach to the lower uterine segment was easy. A Ricard retractor was put in place. |
| pfannenstiel | Active comparator | Procedure: pfannenstiel incisionPfannenstiel Incision, in which the skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 ) cm. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI more than 40 kg/m2
- women scheduled for CS
Key exclusion criteria (1 listed)
- patients receiving steroids or anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transverse supraumbilicaltransverse Supraumbilical Incision, in which the skin incision is a straight transverse skin incision slightly higher than the Pfannenstiel (5- 6) cm. from the upper border of the symphysis pubis The high transverse incision facilitated access to the fascia of the rectus abdominalis | Procedure or surgery | supraumbilical transverse |
| pfannenstiel incisionPfannenstiel Incision, in which the skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 ) cm. | Procedure or surgery | pfannenstiel |
Primary outcome
occurence of surgical site infection
Time frame: one week
occurance of redness, hotness, pus discharge and exudation
2 secondary outcomes
operative time in minutes
Time frame: 2 hours
blood loss in milliliter
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Derived from this study: PubMed 41413498AbdElhady RM, Hamid ASA, El Sayed HM, El Mekkawi SF, Elhossary HMAF, El Kotb AM. Randomized trial assessing transverse supraumbilical incisions for cesarean sections in morbid obese women with pannus. BMC Pregnancy Childbirth. 2025 Dec 18;26(1):91. doi: 10.1186/s12884-025-08530-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M kotb, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transverse supraumbilical and pfannenstiel incision in people with Cesarean Section, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurence of surgical site infection (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02692729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.